解毒消瘤方联合沙利度胺片治疗老年或难治/复发淋巴瘤临床研究  

Clinical Study on Jiedu Xiaoliu Prescription Combined with Thalidomide in the Treatment of Elderly or Refractory Recurrent Lymphoma

作　　者：胡明 胡琦[1] 冯晓卫 魏聪敏 张红玉[1] HU Ming;HU Qi;FENG Xiaowei;WEI Congmin;ZHANG Hongyu(Shanghai Municipal Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)

机构地区：[1]上海中医药大学附属市中医医院,上海200071

出　　处：《中国中医药信息杂志》2023年第5期135-140,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：上海市科学技术委员会科研计划项目(18401903900)。

摘　　要：目的观察解毒消瘤方治疗老年或难治/复发淋巴瘤患者的临床疗效。方法采用随机、双盲、安慰剂对照的前瞻性研究方法,以随机数字表法将70例患者分为治疗组和对照组各35例。2组均予沙利度胺片、阿司匹林肠溶片,100 mg/次,1次/d,睡前口服;同时,治疗组予解毒消瘤方,对照组予中药模拟剂,每日1剂,每日2次,口服,2组均连续治疗12周。观察2组临床客观缓解率(ORR)、临床获益率(CBR),比较2组治疗前后Karnofsky功能状态评分(KPS)、中医症状评分、血清乳酸脱氢酶(LDH)水平、血清β2微球蛋白含量及免疫指标。监测2组安全性指标。结果治疗组30例、对照组26例完成疗效评估。治疗组ORR为13.33%(4/30),对照组ORR为0,治疗组疗效优于对照组(P<0.05);治疗组CBR为90.00%,明显优于对照组的44.30%(P<0.01)。与本组治疗前比较,治疗组治疗后KPS升高、中医症状积分降低(P<0.05),对照组无明显变化;治疗组治疗后血清LDH水平25例正常,优于治疗前(P<0.05),对照组无明显变化;治疗后对照组血清β2微球蛋白含量上升(P<0.05),治疗组无明显变化。治疗组IgG、IgA、κ轻链、λ轻链、补体C3含量较治疗前上升(P<0.05),对照组无明显变化。2组治疗前后淋巴细胞计数无明显变化(P>0.05)。2组治疗前后安全性指标无明显异常;治疗组发生不良事件6例,对照组发生不良事件4例。结论解毒消瘤方联合沙利度胺片节拍性给药法治疗老年或难治/复发淋巴瘤可提高CBR,改善患者中医症状和生活质量,降低肿瘤负荷,疗效明确,不良反应较小;解毒消瘤方可能通过上调血清免疫蛋白水平发挥免疫调节作用,治疗老年或难治/复发淋巴瘤。Objective To explore the clinical efficacy of Jiedu Xiaoliu Prescription in the treatment of elderly or refractory recurrent lymphoma patients.Methods A randomized,double-blind,placebo-controlled prospective method was used.70 patients were divided into treatment group and control group according to random number table method,with 35 cases in each group.Both groups were given thalidomide tablets and aspirin enteric-coated tablets,100 mg/time,once a day,orally before sleep;the treatment group was treated with Jiedu Xiaoliu Prescription,and the control group was treated with TCM simulant,one dosage per day,twice a day,orally.The treatment for both groups lasted for 12 weeks.Clinical objective remission rate(ORR)and clinical benefit rate(CBR)of both groups were observed.Karnofsky performance score(KPS),TCM symptom score,serum lactate dehydrogenase(LDH)level,serumβ2 microglobulin content and immune index of both groups before and after treatment were compared.Safety indicators of both groups were monitored.Results Totally 30 cases in the treatment group and 26 cases in the control group completed the efficacy evaluation.The ORR of the treatment group was 13.33%(4/30),and that of the control group was 0.The curative effect of the treatment group was better than that of the control group(P<0.05).The CBR of the treatment group was 90.00%,which was significantly better than 44.30%of the control group(P<0.01).Compared with before treatment,KPS increased and TCM symptom score decreased in the treatment group,and there was no significant change in the control group;the serum LDH level of 25 cases in the treatment group was normal after treatment,which was better than that before treatment(P<0.05),and there was no significant change in the control group;serumβ2 microglobulin content increased after treatment in the control group(P<0.05),but there was no significant change in the treatment group.The contents of IgG,IgA,κlight chain,λlight chain and complement C3 increased compared with those before treatment(P<0.05),but t

关 键 词：淋巴瘤 解毒消瘤方 沙利度胺 节拍性给药 

分 类 号：R273.34[医药卫生—中西医结合]